High Frequency, High Intensity Transcutaneous Electrical Nerve Stimulation for Endometriosis-related Chronic Pain - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
The study evaluates the effect of TENS (transcutaneous electrical nerve stimulation) as add-on treatment compared with conventional analgesic treatment in patients with endometriosis-related chronic pain. Patients with frequent pain and high pain intensity will be randomized to additional treatment with TENS or conventional treatment for 8 weeks to evaluate the acute effects of TENS treatment (n=40). Patients with endometriosis-related pain that is not frequent or without high pain intensity constitute an external control group. All patients in the study will receive TENS treatment for a total of 16 weeks, for evaluation of long-term effects of TENS treatment.
详细描述
Endometriosis affects approximately one in ten women of childbearing age and may involve both acute pain related to the menstrual cycle and chronic pain. Usual analgesic therapy is often inadequate and/or involves unacceptable side effects and risks with long-term use. Transcutaneous electrical nerve stimulation (TENS) is a patient controlled treatment for pain relief with few side-effects. To date there is limited knowledge of how TENS treatment should be carried out for optimal pain relief in this patient group. The aim of the study is asses the effect of TENS as add-on treatment compared with conventional analgesic treatment in patients with endometriosis-related chronic pain. Patients with frequent pain and high pain intensity (≥ 4 according to Numeric Rating Scale, NRS) will be randomized to additional treatment with TENS or conventional treatment for 8 weeks in order to evaluate the acute effects of TENS treatment (n=40). Patients with endometriosis-related pain that is not frequent or without high pain intensity constitute an external control group. All patients in the study will receive TENS treatment for a total of 16 weeks, for evaluation of long-term effects of TENS treatment in chronic endometriosis-related pain. Prior to start of TENS treatment, all patients receive education on chronic endometriosis-related pain and TENS treatment. Study participants will be asked to participate in a qualitative follow-up within the study including a semi-structured individual interview (n=10-15) before intervention and a semi-structured focus group (n=9-15) interview after completion of TENS treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Consents to participation in the study
- •Verified endometriosis (by laparoscopy or ultrasound).
- •Chronic endometriosis-related pain (> 3 months), available for TENS treatment
- •Functioning, stable endometriosis-specific hormonal drug therapy. The endometriosis-specific drug therapy must be unchanged for the last 3 months and no gynecological surgical procedures for the treatment of endometriosis are planned during the next 7 months (during study participation). The endometriosis-specific drug therapy does not refer to analgesic therapy for symptom relief of endometriosis-related pain.
排除标准
- •Patient with inability to understand and use written and spoken Swedish
- •Patient with pacemaker and/or ICD or other electronic implants
- •Patient with impaired sensation over the painful area
- •Malignant disease with an expected survival <12 months
- •Alcohol or substance abuse
- •Serious untreated psychiatric illness and/or psychological condition that is the primary determinant of the patient's condition
- •Participating in another intervention study with possible impact on current study outcome measures
- •Patient who is using >90 morphine equivalents/day
- •Patient who is electro-acupuncture
- •Pregnancy
结局指标
主要结局
Pain intensity
时间窗: 8 weeks after randomization
Pain intensity according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to endometriosis-related chronic pain
次要结局
- Self-assessed physical activity(16 weeks after start of TENS treatment)
- Pain intensity(16 weeks after start of TENS treatment)
- Physical activity(16 weeks after start of TENS treatment)
- General Self-Efficacy Scale(16 weeks after start of TENS treatment)
- Days of sick-leave(16 weeks after start of TENS treatment)
- Consumption of analgetics(16 weeks after start of TENS treatment)
- Health Related Quality of Life (HRQL) according to SF36(16 weeks after start of TENS treatment)
- Health Related Quality of Life (HRQL) assessed with EHP 30(16 weeks after start of TENS treatment)
- Change in pain intensity(16 weeks after start of TENS treatment)
- Health Related Quality of Life (HRQL) assessed with EQ-5D(16 weeks after start of TENS treatment)
- Insomnia Severity(16 weeks after start of TENS treatment)